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Coronavirus (COVID-19): Information on medicines and medical devices

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.

Please read the information below before contacting the TGA to see if your question is already answered.

8 December 2021
On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine - SPIKEVAX (elasomeran) - making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.
8 December 2021

COVID-19 vaccines undergoing evaluation for provisional registration by the TGA

8 December 2021
The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals 18 years and older.
7 December 2021

COVID-19 treatments that have been provisionally approved for use in Australia

6 December 2021

COVID-19 treatments that have received a provisional determination from the TGA

6 December 2021

COVID-19 treatments undergoing evaluation for provisional registration by the TGA

6 December 2021
TGA grants provisional approval to Celltrion Healthcare Australia Pty Ltd for COVID-19 treatment, regdanvimab (REGKIRONA)
5 December 2021
The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older.
5 December 2021

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

1 December 2021
On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19.

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Further information

Contact TGA Info

Tel: 1800 020 653
Email: info@tga.gov.au

Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.

Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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